Trial Outcomes & Findings for A Phase 1/2A, Single Dose Study Of PF-04383119 In Japanese Patients With Moderate To Severe Pain From Osteoarthritis Of The Knee (NCT NCT00669409)

Results Overview

An AE was any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent: events between first dose of study drug and up to Day 1 through Day 120 (Part 1 and 2) were absent before treatment or that worsened relative to pretreatment state

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

83 participants

Primary outcome timeframe

Day 1 up to Day 92 for tanezumab 10, 25, 50 mcg/kg group and matching placebo group (Part 1, 2); Day 1 up to Day 120 for tanezumab 100 mcg/kg group and matching placebo group (Part 1, 2), 200 mcg/kg group and matching placebo group (Part 1)

Results posted on

2021-02-21

Participant Flow

A total of 83 participants were enrolled in this study, out of which 42 were enrolled in Part 1 and remaining 41 in Part 2.

Participant milestones

Participant milestones
Measure	Tanezumab 10 mcg/kg - Part 1 Single intravenous infusion of tanezumab 10 microgram/kilogram (mcg/kg) over 10 minutes on Day 1 during Part 1.	Tanezumab 25 mcg/kg - Part 1 Single intravenous infusion of tanezumab 25 mcg/kg over 10 minutes on Day 1 during Part 1.	Tanezumab 50 mcg/kg - Part 1 Single intravenous infusion of tanezumab 50 mcg/kg over 10 minutes on Day 1 during Part 1.	Tanezumab 100 mcg/kg - Part 1 Single intravenous infusion of tanezumab 100 mcg/kg over 10 minutes on Day 1 during Part 1.	Tanezumab 200 mcg/kg - Part 1 Single intravenous infusion of tanezumab 200 mcg/kg over 10 minutes on Day 1 during Part 1.	Placebo - Part 1 Placebo matched to either of the single intravenous infusion over 10 minutes on Day 1 during Part 1.	Tanezumab 10 mcg/kg - Part 2 Single intravenous infusion of tanezumab 10 mcg/kg over 10 minutes on Day 1 during Part 2.	Tanezumab 25 mcg/kg - Part 2 Single intravenous infusion of tanezumab 25 mcg/kg over 10 minutes on Day 1 during Part 2.	Tanezumab 50 mcg/kg - Part 2 Single intravenous infusion of tanezumab 50 mcg/kg over 10 minutes on Day 1 during Part 2.	Tanezumab 100 mcg/kg - Part 2 Single intravenous infusion of tanezumab 100 mcg/kg over 10 minutes on Day 1 during Part 2.	Placebo - Part 2 Placebo matched to either of the single intravenous infusion over 10 minutes on Day 1 during Part 2.
Part 1 STARTED	6	6	6	6	6	12	0	0	0	0	0
Part 1 COMPLETED	6	6	6	6	6	12	0	0	0	0	0
Part 1 NOT COMPLETED	0	0	0	0	0	0	0	0	0	0	0
Part 2 STARTED	0	0	0	0	0	0	9	9	9	10	4
Part 2 COMPLETED	0	0	0	0	0	0	9	9	9	9	4
Part 2 NOT COMPLETED	0	0	0	0	0	0	0	0	0	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Tanezumab 10 mcg/kg - Part 1 Single intravenous infusion of tanezumab 10 microgram/kilogram (mcg/kg) over 10 minutes on Day 1 during Part 1.	Tanezumab 25 mcg/kg - Part 1 Single intravenous infusion of tanezumab 25 mcg/kg over 10 minutes on Day 1 during Part 1.	Tanezumab 50 mcg/kg - Part 1 Single intravenous infusion of tanezumab 50 mcg/kg over 10 minutes on Day 1 during Part 1.	Tanezumab 100 mcg/kg - Part 1 Single intravenous infusion of tanezumab 100 mcg/kg over 10 minutes on Day 1 during Part 1.	Tanezumab 200 mcg/kg - Part 1 Single intravenous infusion of tanezumab 200 mcg/kg over 10 minutes on Day 1 during Part 1.	Placebo - Part 1 Placebo matched to either of the single intravenous infusion over 10 minutes on Day 1 during Part 1.	Tanezumab 10 mcg/kg - Part 2 Single intravenous infusion of tanezumab 10 mcg/kg over 10 minutes on Day 1 during Part 2.	Tanezumab 25 mcg/kg - Part 2 Single intravenous infusion of tanezumab 25 mcg/kg over 10 minutes on Day 1 during Part 2.	Tanezumab 50 mcg/kg - Part 2 Single intravenous infusion of tanezumab 50 mcg/kg over 10 minutes on Day 1 during Part 2.	Tanezumab 100 mcg/kg - Part 2 Single intravenous infusion of tanezumab 100 mcg/kg over 10 minutes on Day 1 during Part 2.	Placebo - Part 2 Placebo matched to either of the single intravenous infusion over 10 minutes on Day 1 during Part 2.
Part 2 Withdrawal by Subject	0	0	0	0	0	0	0	0	0	1	0

Baseline Characteristics

A Phase 1/2A, Single Dose Study Of PF-04383119 In Japanese Patients With Moderate To Severe Pain From Osteoarthritis Of The Knee

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Tanezumab 10 mcg/kg n=15 Participants Single intravenous infusion of tanezumab 10 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2.	Tanezumab 25 mcg/kg n=15 Participants Single intravenous infusion of tanezumab 25 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2.	Tanezumab 50 mcg/kg n=15 Participants Single intravenous infusion of tanezumab 50 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2.	Tanezumab 100 mcg/kg n=16 Participants Single intravenous infusion of tanezumab 100 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2.	Tanezumab 200 mcg/kg n=6 Participants Single intravenous infusion of tanezumab 200 mcg/kg over 10 minutes on Day 1 during Part 1.	Placebo n=16 Participants Placebo matched to either of the single intravenous infusion over 10 minutes on Day 1 during Part 1 and Part 2.	Total n=83 Participants Total of all reporting groups
Age, Customized 36-45 Years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	1 Participants n=8 Participants
Age, Customized 46-55 Years	3 Participants n=5 Participants	4 Participants n=7 Participants	3 Participants n=5 Participants	4 Participants n=4 Participants	1 Participants n=21 Participants	4 Participants n=8 Participants	19 Participants n=8 Participants
Age, Customized 56-65 Years	12 Participants n=5 Participants	11 Participants n=7 Participants	10 Participants n=5 Participants	9 Participants n=4 Participants	5 Participants n=21 Participants	11 Participants n=8 Participants	58 Participants n=8 Participants
Age, Customized 66-75 Years	0 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=8 Participants	5 Participants n=8 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	8 Participants n=7 Participants	11 Participants n=5 Participants	12 Participants n=4 Participants	5 Participants n=21 Participants	11 Participants n=8 Participants	57 Participants n=8 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	7 Participants n=7 Participants	4 Participants n=5 Participants	4 Participants n=4 Participants	1 Participants n=21 Participants	5 Participants n=8 Participants	26 Participants n=8 Participants

PRIMARY outcome

Timeframe: Day 1 up to Day 92 for tanezumab 10, 25, 50 mcg/kg group and matching placebo group (Part 1, 2); Day 1 up to Day 120 for tanezumab 100 mcg/kg group and matching placebo group (Part 1, 2), 200 mcg/kg group and matching placebo group (Part 1)

Population: Safety analysis set included all participants who received single intravenous dose of study medication. It was planned to report combined data for Part 1 and 2.

An AE was any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent: events between first dose of study drug and up to Day 1 through Day 120 (Part 1 and 2) were absent before treatment or that worsened relative to pretreatment state

Outcome measures

Outcome measures
Measure	Tanezumab 10 mcg/kg n=15 Participants Single intravenous infusion of tanezumab 10 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2.	Tanezumab 25 mcg/kg n=15 Participants Single intravenous infusion of tanezumab 25 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2.	Tanezumab 50 mcg/kg n=15 Participants Single intravenous infusion of tanezumab 50 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2.	Tanezumab 100 mcg/kg n=16 Participants Single intravenous infusion of tanezumab 100 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2.	Tanezumab 200 mcg/kg n=6 Participants Single intravenous infusion of tanezumab 200 mcg/kg over 10 minutes on Day 1 during Part 1.	Placebo n=16 Participants Placebo matched to either of the single intravenous infusion over 10 minutes on Day 1 during Part 1 and Part 2.
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) AEs	9 Participants	4 Participants	9 Participants	8 Participants	6 Participants	13 Participants
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) SAEs	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Baseline (Part 1 and Part 2)

Population: Safety analysis set included all participants who received single intravenous dose of study medication. It was planned to report combined data for Part 1 and 2.

The HVLT-R is an instrument used to measure verbal learning and memory (recognition and recall). It consists of 3 learning trials: free recall, delayed recall, and yes/no delayed recognition. The total recall score was the sum of 3 'free recall' learning trials, and reflects the participant's ability to learn. The total score ranges from 0 (no memory) to 36 (best memory). Higher score indicated best memory.

Outcome measures

Outcome measures
Measure	Tanezumab 10 mcg/kg n=15 Participants Single intravenous infusion of tanezumab 10 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2.	Tanezumab 25 mcg/kg n=15 Participants Single intravenous infusion of tanezumab 25 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2.	Tanezumab 50 mcg/kg n=15 Participants Single intravenous infusion of tanezumab 50 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2.	Tanezumab 100 mcg/kg n=16 Participants Single intravenous infusion of tanezumab 100 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2.	Tanezumab 200 mcg/kg n=6 Participants Single intravenous infusion of tanezumab 200 mcg/kg over 10 minutes on Day 1 during Part 1.	Placebo n=16 Participants Placebo matched to either of the single intravenous infusion over 10 minutes on Day 1 during Part 1 and Part 2.
Hopkins Verbal Learning Test-Revised (HVLT-R) Total Score at Baseline	27.1 units on a scale Standard Deviation 3.20	26.3 units on a scale Standard Deviation 4.48	24.1 units on a scale Standard Deviation 4.05	26.5 units on a scale Standard Deviation 4.29	27.2 units on a scale Standard Deviation 1.94	25.6 units on a scale Standard Deviation 5.14

PRIMARY outcome

Timeframe: Day 1 (Part 1 and 2)

Population: Safety analysis set included all participants who received single intravenous dose of study medication. Here, 'overall number of participants analyzed' signifies those who were evaluable for this measure. It was planned to report combined data for Part 1 and 2.

The HVLT-R is an instrument used to measure verbal learning and memory (recognition and recall). It consists of 3 learning trials: free recall, delayed recall, and yes/no delayed recognition. The total recall score was the sum of 3 'free recall' learning trials, and reflects the participant's ability to learn. The total score ranges from 0 (no memory) to 36 (best memory). Higher score indicated best memory.

Outcome measures

Outcome measures
Measure	Tanezumab 10 mcg/kg n=6 Participants Single intravenous infusion of tanezumab 10 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2.	Tanezumab 25 mcg/kg n=6 Participants Single intravenous infusion of tanezumab 25 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2.	Tanezumab 50 mcg/kg n=6 Participants Single intravenous infusion of tanezumab 50 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2.	Tanezumab 100 mcg/kg n=6 Participants Single intravenous infusion of tanezumab 100 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2.	Tanezumab 200 mcg/kg n=6 Participants Single intravenous infusion of tanezumab 200 mcg/kg over 10 minutes on Day 1 during Part 1.	Placebo n=12 Participants Placebo matched to either of the single intravenous infusion over 10 minutes on Day 1 during Part 1 and Part 2.
Hopkins Verbal Learning Test-Revised (HVLT-R) Total Score at Day 1	24.7 units on a scale Standard Deviation 2.42	23.2 units on a scale Standard Deviation 4.88	24.3 units on a scale Standard Deviation 2.07	27.3 units on a scale Standard Deviation 5.16	23.7 units on a scale Standard Deviation 2.58	23.5 units on a scale Standard Deviation 3.40

PRIMARY outcome

Timeframe: Day 4/5 (Part 1 and 2)

Population: Safety analysis set included all participants who received single intravenous dose of study medication. Here, 'overall number of participants analyzed' signifies those who were evaluable for this measure. It was planned to report combined data for Part 1 and 2.

The HVLT-R is an instrument used to measure verbal learning and memory (recognition and recall). It consists of 3 learning trials: free recall, delayed recall, and yes/no delayed recognition. The total recall score was the sum of 3 'free recall' learning trials, and reflects the participant's ability to learn. The total score ranges from 0 (no memory) to 36 (best memory). Higher score indicated best memory.

Outcome measures

Outcome measures
Measure	Tanezumab 10 mcg/kg n=6 Participants Single intravenous infusion of tanezumab 10 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2.	Tanezumab 25 mcg/kg n=6 Participants Single intravenous infusion of tanezumab 25 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2.	Tanezumab 50 mcg/kg n=6 Participants Single intravenous infusion of tanezumab 50 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2.	Tanezumab 100 mcg/kg n=6 Participants Single intravenous infusion of tanezumab 100 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2.	Tanezumab 200 mcg/kg n=6 Participants Single intravenous infusion of tanezumab 200 mcg/kg over 10 minutes on Day 1 during Part 1.	Placebo n=12 Participants Placebo matched to either of the single intravenous infusion over 10 minutes on Day 1 during Part 1 and Part 2.
Hopkins Verbal Learning Test-Revised (HVLT-R) Total Score at Day 4/5	27.7 units on a scale Standard Deviation 3.27	26.7 units on a scale Standard Deviation 3.01	27.0 units on a scale Standard Deviation 6.96	29.2 units on a scale Standard Deviation 3.92	26.0 units on a scale Standard Deviation 3.22	27.0 units on a scale Standard Deviation 3.36

PRIMARY outcome

Timeframe: Week 1 (Part 1 and Part 2)

Population: Safety analysis set included all participants who received single intravenous dose of study medication. It was planned to report combined data for Part 1 and 2.

The HVLT-R is an instrument used to measure verbal learning and memory (recognition and recall). It consists of 3 learning trials: free recall, delayed recall, and yes/no delayed recognition. The total recall score was the sum of 3 'free recall' learning trials, and reflects the participant's ability to learn. The total score ranges from 0 (no memory) to 36 (best memory). Higher score indicated best memory.

Outcome measures

Outcome measures
Measure	Tanezumab 10 mcg/kg n=15 Participants Single intravenous infusion of tanezumab 10 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2.	Tanezumab 25 mcg/kg n=15 Participants Single intravenous infusion of tanezumab 25 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2.	Tanezumab 50 mcg/kg n=15 Participants Single intravenous infusion of tanezumab 50 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2.	Tanezumab 100 mcg/kg n=16 Participants Single intravenous infusion of tanezumab 100 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2.	Tanezumab 200 mcg/kg n=6 Participants Single intravenous infusion of tanezumab 200 mcg/kg over 10 minutes on Day 1 during Part 1.	Placebo n=16 Participants Placebo matched to either of the single intravenous infusion over 10 minutes on Day 1 during Part 1 and Part 2.
Hopkins Verbal Learning Test-Revised (HVLT-R) Total Score at Week 1	26.7 units on a scale Standard Deviation 3.35	26.6 units on a scale Standard Deviation 4.81	25.4 units on a scale Standard Deviation 5.32	25.9 units on a scale Standard Deviation 5.15	26.8 units on a scale Standard Deviation 1.72	26.9 units on a scale Standard Deviation 4.15

PRIMARY outcome

Timeframe: Week 2 (Part 1 and Part 2)

Population: Safety analysis set included all participants who received single intravenous dose of study medication. It was planned to report combined data for Part 1 and 2.

The HVLT-R is an instrument used to measure verbal learning and memory (recognition and recall). It consists of 3 learning trials: free recall, delayed recall, and yes/no delayed recognition. The total recall score was the sum of 3 'free recall' learning trials, and reflects the participant's ability to learn. The total score ranges from 0 (no memory) to 36 (best memory). Higher score indicated best memory.

Outcome measures

Outcome measures
Measure	Tanezumab 10 mcg/kg n=15 Participants Single intravenous infusion of tanezumab 10 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2.	Tanezumab 25 mcg/kg n=15 Participants Single intravenous infusion of tanezumab 25 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2.	Tanezumab 50 mcg/kg n=15 Participants Single intravenous infusion of tanezumab 50 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2.	Tanezumab 100 mcg/kg n=16 Participants Single intravenous infusion of tanezumab 100 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2.	Tanezumab 200 mcg/kg n=6 Participants Single intravenous infusion of tanezumab 200 mcg/kg over 10 minutes on Day 1 during Part 1.	Placebo n=16 Participants Placebo matched to either of the single intravenous infusion over 10 minutes on Day 1 during Part 1 and Part 2.
Hopkins Verbal Learning Test-Revised (HVLT-R) Total Score at Week 2	27.0 units on a scale Standard Deviation 4.00	27.1 units on a scale Standard Deviation 4.32	25.7 units on a scale Standard Deviation 4.50	27.0 units on a scale Standard Deviation 5.98	25.5 units on a scale Standard Deviation 1.97	27.1 units on a scale Standard Deviation 3.60

PRIMARY outcome

Timeframe: Week 3 (Part 1 and 2)

Population: Safety analysis set included all participants who received single intravenous dose of study medication. Here, 'overall number of participants analyzed' signifies those who were evaluable for this measure. It was planned to report combined data for Part 1 and 2.

The HVLT-R is an instrument used to measure verbal learning and memory (recognition and recall). It consists of 3 learning trials: free recall, delayed recall, and yes/no delayed recognition. The total recall score was the sum of 3 'free recall' learning trials, and reflects the participant's ability to learn. The total score ranges from 0 (no memory) to 36 (best memory). Higher score indicated best memory.

Outcome measures

Outcome measures
Measure	Tanezumab 10 mcg/kg n=6 Participants Single intravenous infusion of tanezumab 10 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2.	Tanezumab 25 mcg/kg n=6 Participants Single intravenous infusion of tanezumab 25 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2.	Tanezumab 50 mcg/kg n=6 Participants Single intravenous infusion of tanezumab 50 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2.	Tanezumab 100 mcg/kg n=6 Participants Single intravenous infusion of tanezumab 100 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2.	Tanezumab 200 mcg/kg n=6 Participants Single intravenous infusion of tanezumab 200 mcg/kg over 10 minutes on Day 1 during Part 1.	Placebo n=12 Participants Placebo matched to either of the single intravenous infusion over 10 minutes on Day 1 during Part 1 and Part 2.
Hopkins Verbal Learning Test-Revised (HVLT-R) Total Score at Week 3	28.5 units on a scale Standard Deviation 5.75	30.3 units on a scale Standard Deviation 3.93	28.3 units on a scale Standard Deviation 4.27	31.2 units on a scale Standard Deviation 4.49	27.7 units on a scale Standard Deviation 2.07	27.8 units on a scale Standard Deviation 4.45

PRIMARY outcome

Timeframe: Week 4 (Part 1 and Part 2)

Population: Safety analysis set included all participants who received single intravenous dose of study medication. It was planned to report combined data for Part 1 and 2.

The HVLT-R is an instrument used to measure verbal learning and memory (recognition and recall). It consists of 3 learning trials: free recall, delayed recall, and yes/no delayed recognition. The total recall score was the sum of 3 'free recall' learning trials, and reflects the participant's ability to learn. The total score ranges from 0 (no memory) to 36 (best memory). Higher score indicated best memory.

Outcome measures

Outcome measures
Measure	Tanezumab 10 mcg/kg n=15 Participants Single intravenous infusion of tanezumab 10 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2.	Tanezumab 25 mcg/kg n=15 Participants Single intravenous infusion of tanezumab 25 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2.	Tanezumab 50 mcg/kg n=15 Participants Single intravenous infusion of tanezumab 50 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2.	Tanezumab 100 mcg/kg n=16 Participants Single intravenous infusion of tanezumab 100 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2.	Tanezumab 200 mcg/kg n=6 Participants Single intravenous infusion of tanezumab 200 mcg/kg over 10 minutes on Day 1 during Part 1.	Placebo n=16 Participants Placebo matched to either of the single intravenous infusion over 10 minutes on Day 1 during Part 1 and Part 2.
Hopkins Verbal Learning Test-Revised (HVLT-R) Total Score at Week 4	28.5 units on a scale Standard Deviation 3.60	26.4 units on a scale Standard Deviation 5.45	27.2 units on a scale Standard Deviation 4.02	27.6 units on a scale Standard Deviation 4.86	27.0 units on a scale Standard Deviation 3.58	26.9 units on a scale Standard Deviation 4.75

PRIMARY outcome

Timeframe: Week 13 (Part 1 and Part 2)

Population: Safety analysis set included all participants who received single intravenous dose of study medication. It was planned to report combined data for Part 1 and 2.

The HVLT-R is an instrument used to measure verbal learning and memory (recognition and recall). It consists of 3 learning trials: free recall, delayed recall, and yes/no delayed recognition. The total recall score was the sum of 3 'free recall' learning trials, and reflects the participant's ability to learn. The total score ranges from 0 (no memory) to 36 (best memory). Higher score indicated best memory.

Outcome measures

Outcome measures
Measure	Tanezumab 10 mcg/kg n=15 Participants Single intravenous infusion of tanezumab 10 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2.	Tanezumab 25 mcg/kg n=15 Participants Single intravenous infusion of tanezumab 25 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2.	Tanezumab 50 mcg/kg n=15 Participants Single intravenous infusion of tanezumab 50 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2.	Tanezumab 100 mcg/kg n=16 Participants Single intravenous infusion of tanezumab 100 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2.	Tanezumab 200 mcg/kg n=6 Participants Single intravenous infusion of tanezumab 200 mcg/kg over 10 minutes on Day 1 during Part 1.	Placebo n=16 Participants Placebo matched to either of the single intravenous infusion over 10 minutes on Day 1 during Part 1 and Part 2.
Hopkins Verbal Learning Test-Revised (HVLT-R) Total Score at Week 13	28.5 units on a scale Standard Deviation 4.16	26.8 units on a scale Standard Deviation 5.23	27.3 units on a scale Standard Deviation 3.92	28.8 units on a scale Standard Deviation 5.87	23.8 units on a scale Standard Deviation 1.83	26.0 units on a scale Standard Deviation 4.32

PRIMARY outcome

Timeframe: Week 17 (Part 1 and Part 2)

Population: Safety analysis set included all participants who received single intravenous dose of study medication. Week 17 analyses was performed only for treatment arms Tanezumab 100 mcg/kg, 200 mcg/kg and Placebo as per analysis plan. It was planned to report combined data for Part 1 and 2.

The HVLT-R is an instrument used to measure verbal learning and memory (recognition and recall). It consists of 3 learning trials: free recall, delayed recall, and yes/no delayed recognition. The total recall score was the sum of 3 'free recall' learning trials, and reflects the participant's ability to learn. The total score ranges from 0 (no memory) to 36 (best memory). Higher score indicated best memory.

Outcome measures

Outcome measures
Measure	Tanezumab 10 mcg/kg n=16 Participants Single intravenous infusion of tanezumab 10 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2.	Tanezumab 25 mcg/kg n=6 Participants Single intravenous infusion of tanezumab 25 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2.	Tanezumab 50 mcg/kg n=16 Participants Single intravenous infusion of tanezumab 50 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2.	Tanezumab 100 mcg/kg Single intravenous infusion of tanezumab 100 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2.	Tanezumab 200 mcg/kg Single intravenous infusion of tanezumab 200 mcg/kg over 10 minutes on Day 1 during Part 1.	Placebo Placebo matched to either of the single intravenous infusion over 10 minutes on Day 1 during Part 1 and Part 2.
Hopkins Verbal Learning Test-Revised (HVLT-R) Total Score at Week 17	29.3 units on a scale Standard Deviation 5.27	27.3 units on a scale Standard Deviation 2.07	28.9 units on a scale Standard Deviation 3.72	—	—	—

PRIMARY outcome

Timeframe: Baseline, Week 1 (Part 1 and 2)

Population: Full Analysis Set (FAS) included all participants who had received full single intravenous dose of study medication and had at least one entry of electronic diary in both pre and post treatments. Here, 'overall number of participants analyzed' signifies those who were evaluable for this measure. It was planned to report combined data for Part 1 and 2.

VAS assesses participant responses from 0 to 100 (0 = none to 100 = extreme) with 101 point resolution for measuring pain intensity. Higher score indicated greater pain intensity. VAS for current index knee pain was recorded on the electronic diary.

Outcome measures

Outcome measures
Measure	Tanezumab 10 mcg/kg n=15 Participants Single intravenous infusion of tanezumab 10 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2.	Tanezumab 25 mcg/kg n=15 Participants Single intravenous infusion of tanezumab 25 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2.	Tanezumab 50 mcg/kg n=15 Participants Single intravenous infusion of tanezumab 50 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2.	Tanezumab 100 mcg/kg n=16 Participants Single intravenous infusion of tanezumab 100 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2.	Tanezumab 200 mcg/kg n=6 Participants Single intravenous infusion of tanezumab 200 mcg/kg over 10 minutes on Day 1 during Part 1.	Placebo n=14 Participants Placebo matched to either of the single intravenous infusion over 10 minutes on Day 1 during Part 1 and Part 2.
Change From Baseline in Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 1 Baseline	66.5 units on a scale Standard Deviation 22.61	64.5 units on a scale Standard Deviation 12.49	67.9 units on a scale Standard Deviation 8.41	65.0 units on a scale Standard Deviation 13.77	69.7 units on a scale Standard Deviation 9.27	62.3 units on a scale Standard Deviation 18.86
Change From Baseline in Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 1 Change at Week 1	-13.9 units on a scale Standard Deviation 17.75	-29.7 units on a scale Standard Deviation 22.10	-15.0 units on a scale Standard Deviation 19.96	-25.2 units on a scale Standard Deviation 20.35	-46.6 units on a scale Standard Deviation 21.62	-10.1 units on a scale Standard Deviation 9.31

PRIMARY outcome

Timeframe: Baseline, Week 2 (Part 1 and 2)

Population: FAS included all participants who had received full single intravenous dose of study medication and had at least one entry of electronic diary in both pre and post treatments. Here, 'overall number of participants analyzed' signifies those who were evaluable for this measure. It was planned to report combined data for Part 1 and 2.

VAS assesses participant responses from 0 to 100 (0 = none to 100 = extreme) with 101 point resolution for measuring pain intensity. Higher score indicated greater pain intensity. VAS for current index knee pain was recorded on the electronic diary.

Outcome measures

Outcome measures
Measure	Tanezumab 10 mcg/kg n=15 Participants Single intravenous infusion of tanezumab 10 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2.	Tanezumab 25 mcg/kg n=15 Participants Single intravenous infusion of tanezumab 25 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2.	Tanezumab 50 mcg/kg n=15 Participants Single intravenous infusion of tanezumab 50 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2.	Tanezumab 100 mcg/kg n=16 Participants Single intravenous infusion of tanezumab 100 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2.	Tanezumab 200 mcg/kg n=6 Participants Single intravenous infusion of tanezumab 200 mcg/kg over 10 minutes on Day 1 during Part 1.	Placebo n=14 Participants Placebo matched to either of the single intravenous infusion over 10 minutes on Day 1 during Part 1 and Part 2.
Change From Baseline in Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 2	-18.6 units on a scale Standard Deviation 19.82	-29.3 units on a scale Standard Deviation 25.09	-11.3 units on a scale Standard Deviation 19.89	-25.5 units on a scale Standard Deviation 20.48	-25.1 units on a scale Standard Deviation 26.23	-13.2 units on a scale Standard Deviation 16.20

PRIMARY outcome

Timeframe: Baseline, Week 3 (Part 1 and 2)

Population: FAS included all participants who had received full single intravenous dose of study medication and had at least one entry of electronic diary in both pre and post treatments. Here, 'overall number of participants analyzed' signifies those who were evaluable for this measure. It was planned to report combined data for Part 1 and 2.

VAS assesses participant responses from 0 to 100 (0 = none to 100 = extreme) with 101 point resolution for measuring pain intensity. Higher score indicated greater pain intensity. VAS for current index knee pain was recorded on the electronic diary.

Outcome measures

Outcome measures
Measure	Tanezumab 10 mcg/kg n=15 Participants Single intravenous infusion of tanezumab 10 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2.	Tanezumab 25 mcg/kg n=15 Participants Single intravenous infusion of tanezumab 25 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2.	Tanezumab 50 mcg/kg n=15 Participants Single intravenous infusion of tanezumab 50 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2.	Tanezumab 100 mcg/kg n=16 Participants Single intravenous infusion of tanezumab 100 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2.	Tanezumab 200 mcg/kg n=6 Participants Single intravenous infusion of tanezumab 200 mcg/kg over 10 minutes on Day 1 during Part 1.	Placebo n=14 Participants Placebo matched to either of the single intravenous infusion over 10 minutes on Day 1 during Part 1 and Part 2.
Change From Baseline in Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 3	-21.7 units on a scale Standard Deviation 21.33	-35.9 units on a scale Standard Deviation 24.58	-15.3 units on a scale Standard Deviation 22.49	-27.0 units on a scale Standard Deviation 18.19	-23.0 units on a scale Standard Deviation 27.44	-16.3 units on a scale Standard Deviation 20.41

PRIMARY outcome

Timeframe: Baseline, Week 4 (Part 1 and 2)

Population: FAS included all participants who had received full single intravenous dose of study medication and had at least one entry of electronic diary in both pre and post treatments. Here, 'overall number of participants analyzed' signifies those who were evaluable for this measure. It was planned to report combined data for Part 1 and 2.

VAS assesses participant responses from 0 to 100 (0 = none to 100 = extreme) with 101 point resolution for measuring pain intensity. Higher score indicated greater pain intensity. VAS for current index knee pain was recorded on the electronic diary.

Outcome measures

Outcome measures
Measure	Tanezumab 10 mcg/kg n=15 Participants Single intravenous infusion of tanezumab 10 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2.	Tanezumab 25 mcg/kg n=15 Participants Single intravenous infusion of tanezumab 25 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2.	Tanezumab 50 mcg/kg n=15 Participants Single intravenous infusion of tanezumab 50 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2.	Tanezumab 100 mcg/kg n=16 Participants Single intravenous infusion of tanezumab 100 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2.	Tanezumab 200 mcg/kg n=6 Participants Single intravenous infusion of tanezumab 200 mcg/kg over 10 minutes on Day 1 during Part 1.	Placebo n=14 Participants Placebo matched to either of the single intravenous infusion over 10 minutes on Day 1 during Part 1 and Part 2.
Change From Baseline in Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 4	-22.3 units on a scale Standard Deviation 21.30	-37.1 units on a scale Standard Deviation 24.96	-21.8 units on a scale Standard Deviation 21.41	-30.6 units on a scale Standard Deviation 18.15	-46.0 units on a scale Standard Deviation 17.47	-18.2 units on a scale Standard Deviation 21.73

PRIMARY outcome

Timeframe: Baseline, Week 5 (Part 1 and 2)

Population: FAS included all participants who had received full single intravenous dose of study medication and had at least one entry of electronic diary in both pre and post treatments. Here, 'overall number of participants analyzed' signifies those who were evaluable for this measure. It was planned to report combined data for Part 1 and 2.

VAS assesses participant responses from 0 to 100 (0 = none to 100 = extreme) with 101 point resolution for measuring pain intensity. Higher score indicated greater pain intensity. VAS for current index knee pain was recorded on the electronic diary.

Outcome measures

Outcome measures
Measure	Tanezumab 10 mcg/kg n=15 Participants Single intravenous infusion of tanezumab 10 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2.	Tanezumab 25 mcg/kg n=15 Participants Single intravenous infusion of tanezumab 25 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2.	Tanezumab 50 mcg/kg n=15 Participants Single intravenous infusion of tanezumab 50 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2.	Tanezumab 100 mcg/kg n=16 Participants Single intravenous infusion of tanezumab 100 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2.	Tanezumab 200 mcg/kg n=6 Participants Single intravenous infusion of tanezumab 200 mcg/kg over 10 minutes on Day 1 during Part 1.	Placebo n=14 Participants Placebo matched to either of the single intravenous infusion over 10 minutes on Day 1 during Part 1 and Part 2.
Change From Baseline in Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 5	-22.3 units on a scale Standard Deviation 22.25	-38.0 units on a scale Standard Deviation 23.44	-27.2 units on a scale Standard Deviation 24.90	-33.8 units on a scale Standard Deviation 19.02	-50.7 units on a scale Standard Deviation 15.36	-19.8 units on a scale Standard Deviation 23.07

PRIMARY outcome

Timeframe: Baseline, Week 6 (Part 1 and 2)

Population: FAS included all participants who had received full single intravenous dose of study medication and had at least one entry of electronic diary in both pre and post treatments. Here, 'overall number of participants analyzed' signifies those who were evaluable for this measure. It was planned to report combined data for Part 1 and 2.

VAS assesses participant responses from 0 to 100 (0 = none to 100 = extreme) with 101 point resolution for measuring pain intensity. Higher score indicated greater pain intensity. VAS for current index knee pain was recorded on the electronic diary.

Outcome measures

Outcome measures
Measure	Tanezumab 10 mcg/kg n=15 Participants Single intravenous infusion of tanezumab 10 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2.	Tanezumab 25 mcg/kg n=15 Participants Single intravenous infusion of tanezumab 25 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2.	Tanezumab 50 mcg/kg n=15 Participants Single intravenous infusion of tanezumab 50 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2.	Tanezumab 100 mcg/kg n=16 Participants Single intravenous infusion of tanezumab 100 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2.	Tanezumab 200 mcg/kg n=6 Participants Single intravenous infusion of tanezumab 200 mcg/kg over 10 minutes on Day 1 during Part 1.	Placebo n=14 Participants Placebo matched to either of the single intravenous infusion over 10 minutes on Day 1 during Part 1 and Part 2.
Change From Baseline In Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 6	-22.2 units on a scale Standard Deviation 23.49	-39.8 units on a scale Standard Deviation 24.56	-27.7 units on a scale Standard Deviation 24.73	-33.2 units on a scale Standard Deviation 19.14	-51.4 units on a scale Standard Deviation 17.13	-19.5 units on a scale Standard Deviation 24.01

PRIMARY outcome

Timeframe: Baseline, Week 7 (Part 1 and 2)

Population: FAS included all participants who had received full single intravenous dose of study medication and had at least one entry of electronic diary in both pre and post treatments. Here, 'overall number of participants analyzed' signifies those who were evaluable for this measure. It was planned to report combined data for Part 1 and 2.

VAS assesses participant responses from 0 to 100 (0 = none to 10 0= extreme) with 101 point resolution for measuring pain intensity. Higher score indicated greater pain intensity. VAS for current index knee pain was recorded on the electronic diary.

Outcome measures

Outcome measures
Measure	Tanezumab 10 mcg/kg n=15 Participants Single intravenous infusion of tanezumab 10 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2.	Tanezumab 25 mcg/kg n=15 Participants Single intravenous infusion of tanezumab 25 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2.	Tanezumab 50 mcg/kg n=15 Participants Single intravenous infusion of tanezumab 50 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2.	Tanezumab 100 mcg/kg n=16 Participants Single intravenous infusion of tanezumab 100 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2.	Tanezumab 200 mcg/kg n=6 Participants Single intravenous infusion of tanezumab 200 mcg/kg over 10 minutes on Day 1 during Part 1.	Placebo n=14 Participants Placebo matched to either of the single intravenous infusion over 10 minutes on Day 1 during Part 1 and Part 2.
Change From Baseline In Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 7	-18.7 units on a scale Standard Deviation 23.34	-41.2 units on a scale Standard Deviation 24.30	-28.5 units on a scale Standard Deviation 24.77	-34.3 units on a scale Standard Deviation 18.43	-47.9 units on a scale Standard Deviation 14.28	-20.8 units on a scale Standard Deviation 23.62

PRIMARY outcome

Timeframe: Baseline, Week 8 (Part 1 and 2)

Population: FAS included all participants who had received full single intravenous dose of study medication and had at least one entry of electronic diary in both pre and post treatments. Here, 'overall number of participants analyzed' signifies those who were evaluable for this measure. It was planned to report combined data for Part 1 and 2.

VAS assesses participant responses from 0 to 100 (0 = none to 100 = extreme) with 101 point resolution for measuring pain intensity. Higher score indicated greater pain intensity. VAS for current index knee pain was recorded on the electronic diary.

Outcome measures

Outcome measures
Measure	Tanezumab 10 mcg/kg n=15 Participants Single intravenous infusion of tanezumab 10 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2.	Tanezumab 25 mcg/kg n=15 Participants Single intravenous infusion of tanezumab 25 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2.	Tanezumab 50 mcg/kg n=15 Participants Single intravenous infusion of tanezumab 50 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2.	Tanezumab 100 mcg/kg n=16 Participants Single intravenous infusion of tanezumab 100 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2.	Tanezumab 200 mcg/kg n=6 Participants Single intravenous infusion of tanezumab 200 mcg/kg over 10 minutes on Day 1 during Part 1.	Placebo n=14 Participants Placebo matched to either of the single intravenous infusion over 10 minutes on Day 1 during Part 1 and Part 2.
Change From Baseline In Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 8	-17.8 units on a scale Standard Deviation 23.35	-39.8 units on a scale Standard Deviation 24.94	-27.6 units on a scale Standard Deviation 24.86	-34.3 units on a scale Standard Deviation 17.98	-48.2 units on a scale Standard Deviation 16.18	-22.7 units on a scale Standard Deviation 23.67

PRIMARY outcome

Timeframe: Baseline, Week 9 (Part 1 and 2)

Population: FAS included all participants who had received full single intravenous dose of study medication and had at least one entry of electronic diary in both pre and post treatments. Here, 'overall number of participants analyzed' signifies those who were evaluable for this measure. It was planned to report combined data for Part 1 and 2.

VAS assesses participant responses from 0 to 100 (0 = none to 100 = extreme) with 101 point resolution for measuring pain intensity. Higher score indicated greater pain intensity. VAS for current index knee pain was recorded on the electronic diary.

Outcome measures

Outcome measures
Measure	Tanezumab 10 mcg/kg n=15 Participants Single intravenous infusion of tanezumab 10 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2.	Tanezumab 25 mcg/kg n=15 Participants Single intravenous infusion of tanezumab 25 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2.	Tanezumab 50 mcg/kg n=15 Participants Single intravenous infusion of tanezumab 50 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2.	Tanezumab 100 mcg/kg n=16 Participants Single intravenous infusion of tanezumab 100 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2.	Tanezumab 200 mcg/kg n=6 Participants Single intravenous infusion of tanezumab 200 mcg/kg over 10 minutes on Day 1 during Part 1.	Placebo n=14 Participants Placebo matched to either of the single intravenous infusion over 10 minutes on Day 1 during Part 1 and Part 2.
Change From Baseline in Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 9	-16.4 units on a scale Standard Deviation 23.80	-41.2 units on a scale Standard Deviation 26.62	-26.5 units on a scale Standard Deviation 23.77	-33.4 units on a scale Standard Deviation 19.60	-47.6 units on a scale Standard Deviation 11.81	-25.8 units on a scale Standard Deviation 24.77

PRIMARY outcome

Timeframe: Baseline, Week 10 (Part 1 and 2)

Population: FAS included all participants who had received full single intravenous dose of study medication and had at least one entry of electronic diary in both pre and post treatments. Here, 'overall number of participants analyzed' signifies those who were evaluable for this measure. It was planned to report combined data for Part 1 and 2.

VAS assesses participant responses from 0 to 100 (0 = none to 100 = extreme) with 101 point resolution for measuring pain intensity. Higher score indicated greater pain intensity. VAS for current index knee pain was recorded on the electronic diary.

Outcome measures

Outcome measures
Measure	Tanezumab 10 mcg/kg n=15 Participants Single intravenous infusion of tanezumab 10 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2.	Tanezumab 25 mcg/kg n=15 Participants Single intravenous infusion of tanezumab 25 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2.	Tanezumab 50 mcg/kg n=15 Participants Single intravenous infusion of tanezumab 50 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2.	Tanezumab 100 mcg/kg n=16 Participants Single intravenous infusion of tanezumab 100 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2.	Tanezumab 200 mcg/kg n=6 Participants Single intravenous infusion of tanezumab 200 mcg/kg over 10 minutes on Day 1 during Part 1.	Placebo n=14 Participants Placebo matched to either of the single intravenous infusion over 10 minutes on Day 1 during Part 1 and Part 2.
Change From Baseline in Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 10	-15.5 units on a scale Standard Deviation 20.94	-39.9 units on a scale Standard Deviation 28.09	-25.6 units on a scale Standard Deviation 23.44	-31.2 units on a scale Standard Deviation 18.94	-41.2 units on a scale Standard Deviation 14.35	-24.6 units on a scale Standard Deviation 23.50

PRIMARY outcome

Timeframe: Baseline, Week 11 (Part 1 and 2)

Population: FAS included all participants who had received full single intravenous dose of study medication and had at least one entry of electronic diary in both pre and post treatments. Here, 'overall number of participants analyzed' signifies those who were evaluable for this measure. It was planned to report combined data for Part 1 and 2.

VAS assesses participant responses from 0 to 100 (0 = none to 100 = extreme) with 101 point resolution for measuring pain intensity. Higher score indicated greater pain intensity. VAS for current index knee pain was recorded on the electronic diary.

Outcome measures

Outcome measures
Measure	Tanezumab 10 mcg/kg n=15 Participants Single intravenous infusion of tanezumab 10 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2.	Tanezumab 25 mcg/kg n=15 Participants Single intravenous infusion of tanezumab 25 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2.	Tanezumab 50 mcg/kg n=15 Participants Single intravenous infusion of tanezumab 50 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2.	Tanezumab 100 mcg/kg n=16 Participants Single intravenous infusion of tanezumab 100 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2.	Tanezumab 200 mcg/kg n=6 Participants Single intravenous infusion of tanezumab 200 mcg/kg over 10 minutes on Day 1 during Part 1.	Placebo n=14 Participants Placebo matched to either of the single intravenous infusion over 10 minutes on Day 1 during Part 1 and Part 2.
Change From Baseline in Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 11	-17.1 units on a scale Standard Deviation 19.92	-38.0 units on a scale Standard Deviation 25.04	-25.4 units on a scale Standard Deviation 23.41	-30.6 units on a scale Standard Deviation 17.75	-41.4 units on a scale Standard Deviation 20.24	-25.7 units on a scale Standard Deviation 23.27

PRIMARY outcome

Timeframe: Baseline, Week 12 (Part 1 and 2)

Population: FAS included all participants who had received full single intravenous dose of study medication and had at least one entry of electronic diary in both pre and post treatments. Here, 'overall number of participants analyzed' signifies those who were evaluable for this measure. It was planned to report combined data for Part 1 and 2.

VAS assesses participant responses from 0 to 100 (0 = none to 100 = extreme) with 101 point resolution for measuring pain intensity. Higher score indicated greater pain intensity. VAS for current index knee pain was recorded on the electronic diary.

Outcome measures

Outcome measures
Measure	Tanezumab 10 mcg/kg n=15 Participants Single intravenous infusion of tanezumab 10 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2.	Tanezumab 25 mcg/kg n=15 Participants Single intravenous infusion of tanezumab 25 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2.	Tanezumab 50 mcg/kg n=15 Participants Single intravenous infusion of tanezumab 50 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2.	Tanezumab 100 mcg/kg n=16 Participants Single intravenous infusion of tanezumab 100 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2.	Tanezumab 200 mcg/kg n=6 Participants Single intravenous infusion of tanezumab 200 mcg/kg over 10 minutes on Day 1 during Part 1.	Placebo n=14 Participants Placebo matched to either of the single intravenous infusion over 10 minutes on Day 1 during Part 1 and Part 2.
Change From Baseline in Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 12	-16.2 units on a scale Standard Deviation 21.34	-34.7 units on a scale Standard Deviation 24.93	-25.8 units on a scale Standard Deviation 23.06	-30.3 units on a scale Standard Deviation 18.56	-40.3 units on a scale Standard Deviation 22.88	-25.4 units on a scale Standard Deviation 25.76

PRIMARY outcome

Timeframe: Baseline, Week 13 (Part 1 and 2)

Population: FAS included all participants who had received full single intravenous dose of study medication and had at least one entry of electronic diary in both pre and post treatments. Here, 'overall number of participants analyzed' signify those who were evaluable for this measure. It was planned to report combined data for Part 1 and 2.

VAS assesses participant responses from 0 to 100 (0 = none to 100 = extreme) with 101 point resolution for measuring pain intensity. Higher score indicated greater pain intensity. VAS for current index knee pain was recorded on the electronic diary.

Outcome measures

Outcome measures
Measure	Tanezumab 10 mcg/kg n=15 Participants Single intravenous infusion of tanezumab 10 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2.	Tanezumab 25 mcg/kg n=15 Participants Single intravenous infusion of tanezumab 25 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2.	Tanezumab 50 mcg/kg n=15 Participants Single intravenous infusion of tanezumab 50 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2.	Tanezumab 100 mcg/kg n=15 Participants Single intravenous infusion of tanezumab 100 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2.	Tanezumab 200 mcg/kg n=6 Participants Single intravenous infusion of tanezumab 200 mcg/kg over 10 minutes on Day 1 during Part 1.	Placebo n=14 Participants Placebo matched to either of the single intravenous infusion over 10 minutes on Day 1 during Part 1 and Part 2.
Change From Baseline in Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 13	-15.8 units on a scale Standard Deviation 21.64	-32.0 units on a scale Standard Deviation 25.89	-23.0 units on a scale Standard Deviation 22.15	-32.0 units on a scale Standard Deviation 19.67	-31.6 units on a scale Standard Deviation 28.83	-25.4 units on a scale Standard Deviation 26.56

PRIMARY outcome

Timeframe: Baseline, Week 1 (Part 1 and 2)

Population: FAS included all participants who had received full single intravenous dose of study medication and had at least one entry of electronic diary in both pre and post treatments. Here, 'overall number of participants analyzed' signifies those who were evaluable for this measure. It was planned to report combined data for Part 1 and 2.